Viantan

Package Leaflet: Information for the User

Viantan, Powder for Solution for Infusion

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Viantan and what is it used for
• 2. Important information before taking Viantan
• 3. How to take Viantan
• 4. Possible side effects
• 5. How to store Viantan
• 6. Contents of the pack and other information

1. What is Viantan and what is it used for

Viantan is a powder for solution for infusion, which is administered by drip. It contains 13 vitamins (see section 6). Viantan is used to meet the daily vitamin requirements, by administering them directly into the blood, to maintain normal body function in patients who are unable to take vitamins orally with food. Viantan can be administered to adults and children aged 11 and over.

2. Important information before taking Viantan

When not to use Viantan:

• in newborns, infants, and children under 11 years of age.

Warnings and precautions

Before starting treatment with Viantan, you should discuss it with your doctor. Your doctor will take special precautions if you:

• are taking vitamins from other sources;
• have digestive disorders;
• have liver or kidney disorders;
• have a previously diagnosed disease and/or disorder that may cause hypercalcemia and/or hypercalciuria;
• are at risk of vitamin B (cyanocobalamin) deficiency, e.g. if you have short bowel syndrome, inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis), if you are taking metformin (a medicine used to treat diabetes) for more than four months, proton pump inhibitors or H2 receptor blockers (medicines used to treat stomach or duodenal ulcers or to reduce stomach acid, e.g. omeprazole, pantoprazole, etc. or ranitidine, famotidine, etc.) for more than 12 months, if you are a vegan or strict vegetarian, if you are over 75 years old;
• are taking vitamins for a longer period;
• are taking the medicine after a longer period of fasting or malnutrition;
• regularly consume alcohol (more than 3 units of alcohol per day or more than 7 units of alcohol per week).

In case of symptoms of an allergic reaction, such as sweating, skin redness, hives, difficulty breathing, you should immediately inform your doctor or nurse, so that the infusion can be stopped immediately and appropriate treatment can be initiated. Additional monitoring and tests may be performed, including various blood sample analyses and liver function tests, to ensure that the patient's body is handling the administered vitamins properly. Nursing staff may also take action to ensure that the patient is receiving the right amount of vitamins for their needs. The patient may receive other vitamins, in addition to Viantan, to fully meet the body's needs.

Children

The solution should not be administered to newborns, infants, or children under 11 years of age.

Viantan and other medicines

You should tell your doctor, pharmacist, or nurse about all medicines you are taking, or have recently taken, and about any medicines you plan to take. While taking Viantan, you should not take medicines containing vitamin A or vitamin A derivatives (retinoids) due to the risk of vitamin A overdose (see section 3). Viantan may interact with other medicines. You should inform your doctor, pharmacist, or nurse if you are taking any of the following:

• medicines used to treat acne or psoriasis (retinoids), e.g. bexarotene or acitretin;
• medicines used to treat epilepsy, e.g. phenobarbital, phenytoin, carbamazepine, fosphenytoin, and primidone;
• medicines used to treat HIV (antiretroviral, tipranavir);
• antibiotics;
• anti-inflammatory medicines;
• antifungal medicines, e.g. ketoconazole;
• medicines used to treat seizures or bipolar disorder (anticonvulsants), e.g. cycloserine, hydralazine, isoniazid, penicillamine, phenelzine, theophylline, phenytoin, carbamazepine, phenobarbital;
• ethionamide (an antibiotic used to treat tuberculosis);
• medicines that block the action of folic acid (folic acid antagonists), e.g. methotrexate, pyrimethamine;
• deferiprone (a medicine used to treat iron poisoning);
• medicines that can cause increased pressure around the brain (some tetracyclines);
• medicines that prevent blood clotting (acenocoumarol, warfarin, phenprocoumon);
• fluoropyrimidines (medicines used to treat cancer).

Viantan and laboratory tests

Viantan should not be administered to the patient immediately before a blood glucose test or urine test, as it contains vitamin C, which can cause inaccurate test results. One vial of Viantan contains 0.06 mg of biotin. If the patient is to undergo laboratory tests, they must inform their doctor or laboratory staff that they have recently taken Viantan, as biotin can interfere with the results of such tests. Depending on the test, the results may be falsely elevated or falsely low due to biotin. The doctor may order the patient to stop taking Viantan before undergoing laboratory tests. It should also be remembered that other products that may be taken, such as multivitamin preparations or dietary supplements used to improve hair, skin, and nails, may also contain biotin and affect laboratory test results. If the patient is taking such products, they should inform their doctor or laboratory staff.

Pregnancy, breastfeeding, and fertility

Pregnancy
If necessary, the patient may receive Viantan during pregnancy, provided that the indications and dosage are followed to prevent vitamin overdose. The recommended daily dose should not be exceeded, as high doses of vitamin A during pregnancy can cause birth defects.
Breastfeeding
Viantan is not recommended during breastfeeding. If the patient is breastfeeding while taking Viantan, there is a risk of vitamin A overdose in the baby.
Fertility
There is no available data on the effect of Viantan on fertility in men or women.

Driving and using machines

Viantan has no influence or negligible influence on the ability to drive and use machines.

Viantan contains sodium

The medicine contains up to 46 mg of sodium (the main component of common salt) per vial. This corresponds to 2.3% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Viantan

Viantan in the form of powder should first be dissolved in a liquid solution. Then, before administration to the patient, it should be mixed with a larger amount of liquid (solution for parenteral nutrition, glucose, or electrolytes). Viantan is administered into a vein using a drip. The recommended dose is 1 vial per day for adults and children aged 11 and over.

Overdose of Viantan

The risk of vitamin overdose is higher if the patient is receiving other vitamin supplements or if the total dose of supplements is not appropriate for the patient's needs, or if the patient already has a tendency to higher vitamin levels (hypervitaminosis). The most common symptoms of overdose are nausea, vomiting, and diarrhea. Other symptoms of long-term or acute vitamin overdose include:

• dry, flaky skin;
• headache, vomiting, and weakness;
• jaundice;
• increased pressure around the brain with symptoms such as headache, vomiting, confusion about time, and double vision;
• blood clotting disorders;
• abdominal pain;
• symptoms of kidney disease, such as pain when urinating or difficulty urinating;
• high levels of calcium in the blood;
• numbness, tingling, or prickling of the feet or hands;
• lack of coordination and/or falling;
• yellow sweat;
• dark urine. If any of these symptoms occur after taking Viantan, you should inform your doctor.

If you have any further questions about the use of this medicine, you should ask your doctor, pharmacist, or nurse.

4. Possible side effects

Viantan may contain traces of soy protein. Do not use the medicine if you are allergic to peanuts or soy. Like all medicines, Viantan can cause side effects, although not everybody gets them. The following side effects may be serious. If you experience any of the following side effects, you should immediately inform your doctor, who will stop the administration of the medicine:
Unknown (frequency cannot be estimated from the available data)
Severe allergic reactions (anaphylactoid), nausea, vomiting, diarrhea, and a feeling of burning or rash at the injection site. Elevated liver function test results.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your healthcare professional. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Viantan

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month stated.

Storage conditions

Store in a refrigerator (2°C–8°C). If stored at room temperature (below 25°C), the medicine should be used within three months. Viantan should not be used if the reconstituted solution is not clear and colored yellow-orange, or if the vial is damaged. The reconstituted solution should be used immediately.

6. Contents of the pack and other information

What Viantan contains

One vial with 932 mg of dry substance (powder) contains:

• 1. Retinol (vitamin A) 0.99 mg, which corresponds to 3300 IU of retinol (vitamin A) (in the form of retinol palmitate)
• 2. Cholecalciferol 0.005 mg, which corresponds to 200 IU of vitamin D
• 3. all-rac-α-Tocopherol 9.11 mg (vitamin E)
• 4. Phytomenadione 0.15 mg (vitamin K)
• 5. Ascorbic acid 200 mg (vitamin C)
• 6. Thiamine (vitamin B1) 6.00 mg (in the form of thiamine hydrochloride)
• 7. Riboflavin 3.60 mg (vitamin B2) (in the form of riboflavin sodium phosphate)
• 8. Pyridoxine 6.00 mg (vitamin B6) (in the form of pyridoxine hydrochloride)
• 9. Cyanocobalamin 0.005 mg (vitamin B12)
• 10. Folic acid 0.60 mg (vitamin B9)
• 11. Pantothenic acid 15.0 mg (vitamin B5) (in the form of dexpanthenol)
• 12. Biotin (vitamin B7) 0.06 mg
• 13. Nicotinamide 40.0 mg (vitamin B3)

The other ingredients are: glycine, hydrochloric acid (for pH adjustment), sodium glycocholate, soybean phosphatidylcholine (Lipoid S 100), and sodium hydroxide (for pH adjustment).

What Viantan looks like and contents of the pack

Viantan is a powder for solution for infusion. It is a yellow-orange lump or powder supplied in vials made of orange glass. The medicine is packaged in cardboard boxes containing 5 or 10 vials. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

• B. Braun Melsungen AG, Carl-Braun-Straße 1, 34212 Melsungen, Germany

Manufacturer:

• B. Braun Melsungen AG, Am Schwerzelshof 1, 34212 Melsungen, Germany, Postal address: 34209 Melsungen, Germany, Tel.: +49-5661-71-0, Fax: +49-5661-71-4567

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 2019-12-19

Information intended for healthcare professionals only:
Instructions for preparation of the medicinal product for use
When reconstituting and diluting the product in an appropriate solution and/or emulsion for infusion, strict aseptic technique must be followed. Viantan should be administered slowly. The contents of the vial should be dissolved by adding 5 ml of suitable solvent (water for injection, glucose solution 50 mg/ml, or sodium chloride solution 9 mg/ml) and gently shaking to dissolve the lyophilized powder. Do not use if the reconstituted solution is not clear and colored yellow-orange. The reconstituted solution should be used immediately. The powder must be completely dissolved before adding to any of the following medicinal products:

• glucose solution 50 mg/ml,
• sodium chloride solution 9 mg/ml,
• fat emulsion,
• two-chamber mixture for parenteral nutrition containing glucose, electrolytes, and amino acids,
• or three-chamber mixture for parenteral nutrition containing glucose, electrolytes, amino acid solutions, and lipids.

The final solution should be thoroughly mixed. After adding the medicinal product Viantan to the solution for parenteral nutrition, check for any abnormal change in color and/or the presence of precipitate, insoluble complexes, or crystals. Do not mix the medicinal product with other medicinal products, except for those mentioned above, if compatibility and stability have not been demonstrated. Use only if the original seal is not broken and the container is not damaged. For single use only. After use, the container and any unused contents should be disposed of. Any unused medicinal product or waste materials should be disposed of in accordance with local requirements.
Pharmaceutical incompatibilities
Do not mix the medicinal product with other medicinal products, as compatibility has not been tested. If it is necessary to administer incompatible medicines simultaneously, they should be administered through separate intravenous lines. Additives may be incompatible with parenteral nutrition containing the medicinal product Viantan. Vitamin A and thiamine contained in Viantan may react with sulfites contained in parenteral nutrition solutions (e.g. from additives), which may lead to degradation of vitamin A and thiamine. Elevated pH of the solution may enhance the degradation of some vitamins. This should be taken into account when adding alkaline solutions to the mixture containing Viantan. The stability of folic acid may be reduced due to increased calcium concentration in the added medium.